HIV drug levels in hidden reservoirs: new study maps where virus hides
NCT ID NCT04133012
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at 20 men with HIV who were stable on a common drug combination. Researchers took samples of blood, lymph nodes, rectal tissue, fat, and semen to measure how much of the drugs reached these areas. The goal was to understand why HIV can still hide in some tissues even when treatment seems to work. This is a small, completed study that does not test a new treatment but aims to improve knowledge about HIV persistence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dolutegravir, abacavir, lamivudine, tenofovir, emtricitabine
- What this could lead to
- If successful, this could help doctors understand why HIV sometimes persists even when drugs are working, potentially leading to better treatment strategies.
- What could go wrong
- This is a small, observational study with only 20 participants. It does not test a new treatment, so it won't directly improve patient care. Results may not apply to all HIV patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
20 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Jun 2023
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male HIV-1 infected subjects * Age \> or = 18 years old * Currently receiving as first line therapy 7 days a week for at least 18 months with dolutegravir (at 50 mg once a day) and two nucleoside/nucleotide reverse transcriptase inhibitors (abacavir/lamivudine or ,tenofovir/emtricitabine) or * Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir (50 mg once daily) + abacavir/lamivudine followed by dual therapy with dolutegravir + lamivudine for at least 6 months; or * Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir + tenofovir / emtricitabine followed by dual therapy with dolutegravir + lamivudine for at least 6 months. * HIV RNA currently \<50 Cp/mL, , and \<50 Cp/mL 6 months after treatment initiation and \<50 Cp/mL confirmed at 12 months after treatment initiation * Normal PT, APTT and platelet count values at screening * Written and informed consent signed by the person and the investigator (no later than the day of pre-enrollment and prior to any examination carried out as part of the study (article L1122-1-1 of the Public Health Code) * Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme) Exclusion Criteria: * Single HIV-2 infection * Dolutegravir antiretroviral monotherapy * Contraindication to biopsy, taking anticoagulant and antiplatelet drugs * Hemophilia * Symptomatic sexually transmitted infection * Being under guardianship or trusteeship mandate for future protection * Participation in another research involving the human person, of category 1 or 2, * Associated treatments (Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, Rifampicin, St. John's Wort)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Antoine-Beclere Hospital
Clamart, France
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Bicetre Hospital
Le Kremlin-Bicêtre, France
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Bichat Hospital
Paris, France
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Hotel Dieu Hospital
Paris, France
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Necker Hospital
Paris, France
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Pitie Salpetriere Hospital
Paris, France
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Saint Antoine Hospital
Paris, 75012, France
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Tourcoing Hospital
Tourcoing, 59208, France
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